Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQK 2023-01-21

VX1+

Applicant Volta Medical

K-Number K223516

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FMI 2023-01-20

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

Applicant Pikdare Spa

K-Number K203792

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FAJ 2023-01-20

CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)

Applicant Olympus Medical Systems Corporation

K-Number K221683

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KPR 2023-01-20

DRX - Compass

Applicant Carestream Health, Inc.

K-Number K223842

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FPA 2023-01-20

FlowArt® Needle-Free Split Septum Valve

Applicant Asset Medikal Tasarim San Tic As.

K-Number K222889

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LIT 2023-01-20

Highlander 014 PTA Balloon Dilatation Catheter

Applicant C.R. Bard, Inc.

K-Number K223177

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GEX 2023-01-20

Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V

Applicant Quanta System Spa

K-Number K223404

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OLO 2023-01-20

Blueprint Mixed Reality system

Applicant Tornier S.A.S.

K-Number K222510

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QRL 2023-01-20

TD-5010 Lancing Device and TD-5084 Sterile Lancets

Applicant Gostar Co., Ltd.

K-Number K221419

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LLZ 2023-01-20

Advanced MyHip Planner

Applicant Medacta International S.A.

K-Number K221725

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OUR 2023-01-20

ZESPIN SI Joint Fusion System

Applicant Aegis Spine, Inc.

K-Number K223521

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NGZ 2023-01-20

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml

Applicant Thermo Fisher Scientific

K-Number K221899

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